[113th Congress Public Law 51]
[From the U.S. Government Publishing Office]
[[Page 127 STAT. 579]]
Public Law 113-51
113th Congress
An Act
To amend the Public Health Service Act to establish safeguards and
standards of quality for research and transplantation of organs infected
with human immunodeficiency virus (HIV). <<NOTE: Nov. 21, 2013 - [S.
330]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: HIV Organ Policy
Equity Act.>>
SECTION 1. <<NOTE: 42 USC 201 note.>> SHORT TITLE.
This Act may be cited as the ``HIV Organ Policy Equity Act''.
SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
(a) Standards of Quality for the Acquisition and Transportation of
Donated Organs.--
(1) Organ procurement and transplantation network.--Section
372(b) of the Public Health Service Act (42 U.S.C. 274(b)) is
amended--
(A) in paragraph (2)(E), by striking ``, including
standards for preventing the acquisition of organs that
are infected with the etiologic agent for acquired
immune deficiency syndrome''; and
(B) by adding at the end the following:
``(3) Clarification.--In adopting and using standards of
quality under paragraph (2)(E), the Organ Procurement and
Transplantation Network may adopt and use such standards with
respect to organs infected with human immunodeficiency virus (in
this paragraph referred to as `HIV'), provided that any such
standards ensure that organs infected with HIV may be
transplanted only into individuals who--
``(A) are infected with HIV before receiving such
organ; and
``(B)(i) are participating in clinical research
approved by an institutional review board under the
criteria, standards, and regulations described in
subsections (a) and (b) of section 377E; or
``(ii) if the Secretary has determined under section
377E(c) that participation in such clinical research, as
a requirement for such transplants, is no longer
warranted, are receiving a transplant under the
standards and regulations under section 377E(c).''.
(2) Conforming amendment.--Section 371(b)(3)(C) of the
Public Health Service Act (42 U.S.C. 273(b)(3)(C); relating to
organ procurement organizations) is amended by striking
``including arranging for testing with respect to preventing the
acquisition of organs that are infected with the etiologic agent
for acquired immune deficiency syndrome'' and inserting
[[Page 127 STAT. 580]]
``including arranging for testing with respect to identifying
organs that are infected with human immunodeficiency virus
(HIV)''.
(3) Technical amendments.--Section 371(b)(1) of the Public
Health Service Act (42 U.S.C. 273(b)(1)) is amended by--
(A) striking subparagraph (E);
(B) redesignating subparagraphs (F) and (G) as
subparagraphs (E) and (F), respectively;
(C) striking ``(H) has a director'' and inserting
``(G) has a director''; and
(D) in subparagraph (H)--
(i) in clause (i) (V), by striking ``paragraph
(2)(G)'' and inserting ``paragraph (3)(G)''; and
(ii) in clause (ii), by striking ``paragraph
(2)'' and inserting ``paragraph (3)''.
(b) Publication of Research Guidelines.--Part H of title III of the
Public Health Service Act (42 U.S.C. 273 et seq.) is amended by
inserting after section 377D the following:
``SEC. 377E. <<NOTE: Deadlines. 42 USC 274f-5.>> CRITERIA,
STANDARDS, AND REGULATIONS WITH RESPECT
TO ORGANS INFECTED WITH HIV.
``(a) In General.--Not later than 2 years after the date of the
enactment of the HIV Organ Policy Equity Act, the Secretary shall
develop and publish criteria for the conduct of research relating to
transplantation of organs from donors infected with human
immunodeficiency virus (in this section referred to as `HIV') into
individuals who are infected with HIV before receiving such organ.
``(b) Corresponding Changes to Standards and Regulations Applicable
to Research.--Not later than 2 years after the date of the enactment of
the HIV Organ Policy Equity Act, to the extent determined by the
Secretary to be necessary to allow the conduct of research in accordance
with the criteria developed under subsection (a)--
``(1) the Organ Procurement and Transplantation Network
shall revise the standards of quality adopted under section
372(b)(2)(E); and
``(2) the Secretary shall revise section 121.6 of title 42,
Code of Federal Regulations (or any successor regulations).
``(c) Revision of Standards and Regulations Generally.--Not later
than 4 years after the date of the enactment of the HIV Organ Policy
Equity Act, and annually thereafter, the Secretary, shall--
``(1) review the results of scientific research in
conjunction with the Organ Procurement and Transplantation
Network to determine whether the results warrant revision of the
standards of quality adopted under section 372(b)(2)(E) with
respect to donated organs infected with HIV and with respect to
the safety of transplanting an organ with a particular strain of
HIV into a recipient with a different strain of HIV;
``(2) <<NOTE: Determination.>> if the Secretary determines
under paragraph (1) that such results warrant revision of the
standards of quality adopted under section 372(b)(2)(E) with
respect to donated organs infected with HIV and with respect to
transplanting an organ with a particular strain of HIV into a
recipient with a different strain of HIV, direct the Organ
Procurement and
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Transplantation Network to revise such standards, consistent
with section 372 and in a way that ensures the changes will not
reduce the safety of organ transplantation; and
``(3) in conjunction with any revision of such standards
under paragraph (2), revise section 121.6 of title 42, Code of
Federal Regulations (or any successor regulations).''.
SEC. 3. CONFORMING AMENDMENT TO TITLE 18 OF THE UNITED STATES
CODE.
Section 1122(a) of title 18, United States Code, is amended by
inserting ``or in accordance with all applicable guidelines and
regulations made by the Secretary of Health and Human Services under
section 377E of the Public Health Service Act'' after ``research or
testing''.
Approved November 21, 2013.
LEGISLATIVE HISTORY--S. 330 (H.R. 698):
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HOUSE REPORTS: No. 113-181, Pt. 1 (Comm. on Energy and Commerce)
accompanying H.R. 698.
CONGRESSIONAL RECORD, Vol. 159 (2013):
June 17, considered and passed Senate.
Nov. 12, considered and passed House.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2013):
Nov. 21, Presidential statement.
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